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Implementation of Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery, a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03928678
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fatma Adel El sherif,MD, Assiut University

Brief Summary:
The aim of our study is to determine the effect of implementation of the ERAS (enhanced recovery after surgery) protocol in our institute and its impact on hospital length of stay and outcome of surgery.

Condition or disease Intervention/treatment Phase
Cancer of Colon Procedure: enhanced recovery after surgery program in colorectal cancer surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Enhanced Recovery After Surgery Program (ERAS) in Colorectal Cancer Surgery
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

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Arm Intervention/treatment
Active Comparator: thefast track (FTS group) Procedure: enhanced recovery after surgery program in colorectal cancer surgery
to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.

Placebo Comparator: Thecontrolgroup Procedure: enhanced recovery after surgery program in colorectal cancer surgery
to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.




Primary Outcome Measures :
  1. length of hospital stay in days [ Time Frame: 4 days ]
    length of hospital stay in days



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≤ 60 years,
  • Good nutrition,
  • No systemic infection and
  • Elective laparoscopic surgery

Exclusion Criteria:

  • Age >75 years,
  • Malnutrition or an organ system infection
  • Associated with obstruction, bleeding, emergency surgery or other surgical intervention
  • Tumor with extensive metastasis
  • Prior to surgery, patient was fasting, underwent gastrointestinal decompression and received nutritional support
  • Previous history of abdominal surgery
  • Patient have previously undergone gastrostomy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928678


Locations
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Egypt
South Egypt Cancer Instuite Recruiting
Assuit, Egypt, 171516
Contact: fatma A el sherif, lecturer    088233018    fatma_anesthesia@yahoo.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Fatma Adel El sherif,MD, lecturer of anesthesia, Assiut University
ClinicalTrials.gov Identifier: NCT03928678     History of Changes
Other Study ID Numbers: 458
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases